System and Method for Forming a Custom Medical Mask Using an Orientation Device

ABSTRACT

According to one embodiment, forming a custom medical mask includes, while an oral appliance is positioned in a user&#39;s mouth to receive the user&#39;s teeth and is coupled to an orientation device, applying an impression material over the device and the user&#39;s face, such that the impression material conforms to the device and to the user&#39;s unique facial features. The impression material may be removed together with the device and a cast may be created using the impression material together with the device as a mold, such that the cast conforms to the impression material and the device. A deformable material may be applied to the cast to form a custom medical mask for the user, such that the deformable material conforms to the cast. The custom medical mask is custom-fitted to the user&#39;s unique facial features and custom-oriented to the user&#39;s teeth.

TECHNICAL FIELD

This invention relates generally to masks for use in medical and otherclinical applications, and more particularly to a system and method forforming a custom medical mask using an orientation device.

BACKGROUND

Many people experience breathing problems on a recurring basis, whichoften result in sleep disordered breathing (i.e., difficulty sleeping,snoring, or other more serious conditions such as obstructive sleepapnea). As technology advances, people with such breathing problemsdemand increased performance and comfort. Previous devices for improvinga user's breathing have included face masks, nose masks, or nasalinserts that help deliver air to the user's nose at positive pressure.These devices help force open the user's breathing passage and therebyimprove the user's breathing. However, previous devices have oftenprovided an inadequate fit and thus have caused discomfort for users andfailed to adequately prevent leakage.

Overview

According to one embodiment, a method for use in forming a custommedical mask for a particular user includes, while an oral appliance ispositioned in the particular user's mouth to receive the particularuser's teeth and is coupled to an orientation device using a post of theoral appliance, applying an impression material over the orientationdevice and the particular user's face including at least the particularuser's mouth and a portion of the particular user's nose surrounding theparticular user's nostrils, such that the impression material conformsto the orientation device and to the particular user's unique facialfeatures. The impression material may be removed from the particularuser's face together with the orientation device. A cast of theparticular user's face may be created using the impression materialtogether with the orientation device as a mold, such that the castconforms to the impression material and the orientation device. Adeformable material may be applied to the cast of the particular user'sface to form a custom medical mask for the particular user, such thatthe deformable material conforms to the cast. The custom medical maskmay be custom-fitted to the particular user's unique facial features andcustom-oriented to the particular user's teeth.

According to another embodiment, a system for use in forming a custommedical mask for a particular user includes an oral appliance, anorientation device, and an impression material. The oral applianceincludes an upper arch configured to be positioned within a particularuser's mouth to receive the particular user's upper teeth and a postcoupled to the upper arch and configured to protrude from the particularuser's mouth when the upper arch is positioned within the particularuser's mouth. The orientation device includes an elongated tubularmember configured to receive the oral appliance post to couple theorientation device to the oral appliance and a restraining structureconfigured to substantially limit the movement of the orientation devicerelative to the oral appliance. The impression material is conformed tothe orientation device and the particular user's unique facial featuresand custom-oriented to the particular user's teeth via the orientationdevice and the oral appliance.

According to another embodiment, a custom medical mask includes adeformable thermoplastic polymer and a locking mechanism. The deformablethermoplastic polymer is conformed to a custom mold of the particularuser's unique facial features and custom-fitted to the particular user'sunique facial features, the particular user's unique facial featuresincluding portions of the particular user's face surrounding theparticular user's mouth and at least portions of the particular user'snose, having been formed using a custom mold of the particular user'sunique facial features. The locking mechanism is configured to receiveand secure a post of an oral appliance to maintain a custom orientationbetween the oral appliance and the custom-fitted thermoplastic polymer.

Certain embodiments may provide one or more technical advantages.Certain embodiments may provide a custom medical mask that conformssubstantially optimally to a user's unique facial features. Certainembodiments may provide a custom medical mask that may couple to an oralappliance to provide an improved fit based on the precise customorientation or positional relationship between a user's unique facialstructure and the user's teeth. Certain embodiments may provide aprocess for use in forming a custom medical mask that maintains aprecise custom orientation or positional relationship between a user'sunique facial features and the user's teeth through each step of theprocess to ensure that the custom medical mask has an optimal fit,customized for the user. Certain embodiments may provide improved fit,increased comfort, reduced leakage, and improved performance, whetherfor treating sleep disordered breathing, administering anesthesia, orany other suitable purpose for which the custom medical mask is used.Certain embodiments may provide all, some, or none of these advantages.Certain embodiments may provide one or more other technical advantages,one or more of which may be apparent to those skilled in the art fromthe figures, descriptions, and claims included herein.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention and certainof its advantages, reference is now made to the following description,taken in conjunction with the accompanying drawings, in which:

FIGS. 1A and 1B illustrate an example custom medical mask;

FIGS. 2A through 2J illustrate example devices and steps for use informing a custom medical mask; and

FIGS. 3A and 3B illustrate an example orientation device for use informing a custom medical mask.

DESCRIPTION OF EXAMPLE EMBODIMENTS

FIGS. 1A and 1B illustrate an example custom medical mask 10, customizedfor a particular user. Custom medical mask 10 is a mask custom formedfor the particular user and suited to assist in a medical treatment ortherapy for the particular user. Generally, a precise orientation orpositional relationship exists between a user's unique facial featuresand the user's teeth that is substantially fixed and stable. Custommedical mask 10 may be formed using an impression of the particularuser's unique facial features and an orientation device to establish anoptimal fit, customized for the particular user, based in part on theprecise orientation or positional relationship between the particularuser's unique facial features and the particular user's teeth. Custommedical mask 10 may conform substantially optimally to the particularuser's unique facial features. Custom medical mask 10 may couple to anoral appliance to maintain a custom orientation or positionalrelationship between custom medical mask 10 and the particular user'steeth. In certain embodiments, custom medical mask 10 may include body12, fitting 14, and locking mechanism 16.

In certain embodiments, body 12 may be formed from a thin sheet ofdeformable material configured to cover at least a portion of theparticular user's face. Body 12 may be configured to cover theparticular user's mouth and at least a portion of the particular user'snose surrounding the nostrils. In a particular embodiment, body 12 maybe configured to cover only the soft cartilaginous portions of theparticular user's nose and portions of the particular user's face to thesides of and below the soft cartilaginous portions of the nose, but notto cover the hard bony portions of the nose generally above the softcartilaginous portions of the nose. Body 12 may be formed from a singlesheet of deformable material or may be formed from multiple sheets ofdeformable material coupled to one another.

In certain embodiments, body 12 may include a suitable thermoplasticpolymer and suitable fillers, stabilizers, coloring agents,antioxidants, antimicrobial agents, and/or other materials. In certainembodiments, body 12 may include a light curing material such as thematerial sold under the name TRIAD by DENTSPLY INTERNATIONAL INC. Suchmaterials are known in various contexts to those skilled in the art.

In a particular embodiment, body 12 may include, possibly in addition toone or more other materials, one or more of the thermoplasticpolycaprolactone polymers or other aliphatic polyesters described inU.S. Pat. Nos. 4,784,123 and 5,112,225 and product literature of UNIONCARBIDE CORPORATION. One or more polycaprolactone polymers may have theformula:

where R is an aliphatic hydrocarbon and n may range betweenapproximately 300 to approximately 650. However, the present inventioncontemplates using any suitable polycaprolactone polymer.

For example, body 12 may include one or more of the TONE P-700, TONEP-767, or TONE P-787 polycaprolactone polymers manufactured by UNIONCARBIDE CORPORATION, singly or in any combination. In a particularexample, body 12 may include approximately thirty parts by volume ofTONE R-700 and sixty parts by volume of TONE P-767, together withapproximately ten parts by volume of one or more other polymers,depending upon the application and particular needs.

TONE polycaprolactone polymers are described in U.S. Pat. Nos. 4,784,123and 5,112,225 and product literature of UNION CARBIDE CORPORATION asincluding homopolymers, block copolymers, graft copolymers, or otherpolymers containing epsilon-caprolactone. Polymerization may beinitiated using a diol, for example and without limitation, ethyleneglycol, diethylene glycol, neopentyl glycol, butane diol, hexane diol,or any other appropriate diol. The diol may have the formula:

HO—R—OH   (2)

where R is an aliphatic hydrocarbon. In general, polycaprolactonepolymers may display desirable dimensional stability andthermoplasticity during cooling, biocompatibility, and a variety ofother characteristics making them suitable for use in formingembodiments of custom medical mask 10.

In certain embodiments, fitting 14 may include any suitable structure toconnect custom medical mask 10 to a suitable clinical gas deliverysystem. For example, fitting 14 may represent an acrylic, male-type hoseconnector that couples to an opening in body 12. As another example,fitting 14 may represent a gasket surrounding an opening into body 12.Fitting 14 may include a structure configured to connect custom medicalmask 10 to multiple hoses. A suitable clinical gas delivery system maybe a Continuous Positive Air Pressure (CPAP) system, a Bilevel PositiveAir Pressure (BiPAP) system, or other system configured to deliver air,oxygen, anesthetic, or other gases to the particular user wearing custommedical mask 10.

Locking mechanism 16 may represent one or more structures configured tocouple and secure custom medical mask 10 to an oral appliance 20. Incertain embodiments, locking mechanism 16 may represent a sleeve with anopening configured to receive a post 18 of oral appliance 20 to couplecustom medical mask 10 to oral appliance 20. Locking mechanism 16 mayfurther include one or more threaded openings configured to receive oneor more set screws 17 to retain post 18 of oral appliance 20 withinlocking mechanism 16.

FIGS. 2A through 2J illustrate example devices and steps for use informing custom medical mask 10 for the particular user. In certainembodiments, one or more of these devices and steps may be used to forma custom medical mask 10 that maintains a precise custom orientation orpositional relationship between the particular user's unique facialfeatures and the particular user's teeth through each step of theforming process to ensure that custom medical mask 10 has an optimalfit, customized for the particular user. Certain embodiments of custommedical mask 10 formed using one or more of these devices and steps mayprovide improved fit, increased comfort, reduced leakage, and improvedperformance, whether for treating sleep disordered breathing,administering anesthesia, or any other suitable purpose for which custommedical mask 10 is used.

As shown in FIG. 2A, oral appliance 20 with post 18 may be inserted intothe particular user's mouth. In certain embodiments, oral appliance 20may include upper arch 22 and lower arch 24. Upper arch 22 may beconfigured to receive the particular user's upper teeth. Lower arch 24may be configured to receive the particular user's lower teeth. As usedherein, reference to the particular user's teeth is meant to include anyone or more of the user's teeth depending on the structure of the oralappliance. Oral appliance 20 may include one or more structuresconfigured to couple upper arch 22 to lower arch 24. For example, theseone or more structures may be configured to position lower arch 24relative to upper arch 22 to define a particular position for theparticular user's lower jaw relative to the particular user's upper jaw.In certain embodiments, oral appliance 20 may represent a bite registeror wax mold suitable to receive either or both of the particular user'supper and lower teeth.

In certain embodiments, post 18 may represent one or more structuresconfigured to project out of the particular user's mouth when oralappliance 20 is positioned in the particular user's mouth. In aparticular embodiment, post 18 may represent a substantially straight,cylindrical projection that may be greater than one inch in length. Post18 may have a substantially circular, square, or any other appropriatelyshaped cross-section. One or more components of oral appliance 20 may becustom-shaped to fit to the particular user's unique dental structure.Oral appliance 20 with post 18 may serve to register or define anorientation or positional relationship relative to the particular user'steeth. In certain embodiments, post 18 may be removable from oralappliance 20.

Orientation device 30 may represent one or more structures configured todefine and maintain a precise custom orientation or positionalrelationship between the particular user's unique facial features andthe particular user's teeth during the fabrication of custom medicalmask 10. As shown in FIG. 2B, orientation device 30 may be coupled topost 18 of oral appliance 20 when oral appliance 20 is positioned withinthe particular user's mouth to establish an orientation or positionalrelationship between orientation device 30 and the particular user'steeth. Orientation device 30 may be coupled to oral appliance 20 priorto or subsequent to the positioning of oral appliance 20 in theparticular user's mouth.

FIGS. 3A and 3B illustrate an example orientation device 30 for use informing custom medical mask 10. In certain embodiments, orientationdevice 30 may include sleeve 34, one or more breathing tubes 36, and arestraining structure, such as lip shield 32. Sleeve 34 represents astructure configured to align orientation device 30 with post 18 of oralappliance 20. In a particular embodiment, sleeve 34 may represent acylindrical tube configured to receive post 18. Although shown in FIGS.3A and 3B with a substantially circular cross-section, in alternativeembodiments sleeve 34 may have a square or other suitable cross-sectionto align orientation device 30 with post 18. In embodiments oforientation device 30 that include one or more breathing tubes 36,breathing tube 36 may provide a channel through which the particularuser may breathe. In embodiments of orientation device 30 that include arestraining structure, such as lip shield 32, the restraining structuremay operate to restrain orientation device 30 from moving from aselected position along the length of post 18. For example, lip shield32 may represent one or more structures configured to be positionedbetween the particular user's teeth and lips to restrain orientationdevice 30. As a more particular example, lip shield 32 may represent aflange projecting in a direction generally perpendicular to the longaxis of sleeve 34.

FIG. 2C illustrates an example mask mold 40 with impression material 50for use in forming custom medical mask 10. In certain embodiments, maskmold 40 may be used together with impression material 50 to create animpression of certain unique physical features of the particular user'sface. For example, mask mold 40 may represent a tray that may begenerally shaped to conform to at least a portion of a generic user'sface. Mask mold 40 may include one or more plastics, acrylics, or otherappropriate materials. Mask mold 40 may include an opening 42corresponding to the location of a generic user's mouth. Impressionmaterial 50 may represent a deformable material used to create animpression of at least a portion of the particular user's face. In aparticular embodiment, impression material 50 may include a dentalirreversible alginate or other appropriate material used to createimpressions. In operation, impression material 50 may be applied to atleast a portion of the inside surface of mask mold 40.

As shown in FIG. 2D, mask mold 40 with impression material 50 may thenbe applied to the particular user's face, while oral appliance 20 ispositioned in the particular user's mouth and coupled to orientationdevice 30. Alternatively, impression material 50 may be applied directlyto the particular user's face without the use of mask mold 40.Impression material 50 may conform to at least a portion of orientationdevice 30. An interior surface of impression material 50 directly orindirectly contacts the particular user's face and conforms to theparticular user's unique facial features. As a result, impressionmaterial 50 may establish a precise custom orientation or positionalrelationship between the conformed interior surface of impressionmaterial 50 and orientation device 30, which further establishes aprecise custom orientation or positional relationship between theconformed interior surface of impression material 50 and oral appliance20, thereby establishing a precise custom orientation or positionalrelationship between the conformed interior surface of impressionmaterial 50 and the particular user's teeth. As impression material 50becomes firm, impression material 50 may retain these establishedorientations or positional relationships.

As shown in FIG. 2E, once impression material 50 has become firm enoughto retain the impression of the particular user's face, impressionmaterial 50 together with mask mold 40 and orientation device 30 may beremoved from the particular user's face, such that the orientation orpositional relationship between the conformed interior surface ofimpression material 50 and orientation device 30 is maintained.

As shown in FIG. 2F, after impression material 50, mask mold 40, andorientation device 30, have been removed, post 60 may be inserted intosleeve 34 of orientation device 30. Post 60 represents one or morestructures that correspond to post 18 of oral appliance 20. In certainembodiments, post 18 may be removed from oral appliance 20 withorientation device 30 when impression material 50 and mask mold 40 areremoved from the particular user's face and used as post 60. In certainembodiments, post 60 may be a structure, separate from post 18, with ashape the same as or substantially similar to the shape of post 18. Inan alternative embodiment, post 60 may be integral to orientation device30. Impression material 50 together with orientation device 30 and post60 may be used to create a cast of at least a portion of the particularuser's face. For example, a cast of at least a portion of the particularuser's face may be created using impression material 50 as a mold forthe cast. In certain embodiments, an exterior surface of cast 70conforms to a portion of the interior surface of impression material 50and cast 70 couples to orientation device 30, such that an orientationor positional relationship is established between the conformed exteriorsurface of cast 70 and orientation device 30 based on the orientation orpositional relationship between the interior surface of impressionmaterial 50 and orientation device 30.

FIG. 2G illustrates an example cast 70 of a portion of the particularuser's face. In certain embodiments, cast 70 includes orientation device30 with post 60. Cast 70 may include any appropriate casting material,such as a suitable dental plaster or stone. Portions of orientationdevice 30 may be trimmed or otherwise removed, as shown in FIG. 2H.

As shown in FIG. 2I, in certain embodiments, chamber mold 80 mayrepresent one or more materials applied to cast 70 to model an openchamber in the region surrounding the particular user's mouth and lips.Chamber mold 80 may provide for the creation of an oral chamber incustom medical mask 10 when cast 70 is used to create custom medicalmask 10. An oral chamber in custom medical mask 10 may be advantageousfor allowing movement of the particular user's mouth and/or lips whenthe particular user is wearing custom medical mask 10.

As shown in FIG. 2J, in certain embodiments, locking mechanism 16 may becoupled to post 60. For example, post 60 may be received and securedwithin locking mechanism 16. In certain embodiments, post 60 may besecured within locking mechanism 16 by adjusting one or more set screws17 to contact and apply pressure to post 60.

As shown in FIG. 2K, in certain embodiments, one or more pieces of thindeformable material 90 may be applied to cast 70 to form body 12 ofcustom medical mask 10. An interior surface of deformable material 90may directly or indirectly contact cast 70 and conform to the conformedexterior surface of cast 70. In certain embodiments, deformable material90 may conform to post 60, with or without locking mechanism 16, and mayestablish an orientation or positional relationship between theconformed interior surface of deformable material 90 and post 60 and/orlocking mechanism 16, further establishing an orientation or positionalrelationship between the conformed interior surface of deformablematerial 90 and orientation device 30. In embodiments in whichdeformable material 90 is allowed to conform to post 60 without lockingmechanism 16, locking mechanism 16 may subsequently be coupled to post60 and one or more additional pieces of thin deformable material 90, orother appropriate material, may be applied to conform to lockingmechanism 16.

In certain embodiments, a thin piece of deformable material 90 appliedto cast 70 may be a mask blank as described in U.S. Pat. No. 6,857,428.As one example, an appropriate thin piece of deformable material 90 maybe obtained from CHESAPEAKE MEDICAL PRODUCTS, INC.

Prior to applying the one or more pieces of thin deformable material 90to cast 70, the material is placed in a deformable state. For example,where the deformable material 90 includes one or more polycaprolactonepolymers, the deformable material 90 may be heated in a microwave oven,in water or other non-solvent neutral liquid, or in any other suitablemanner to between approximately 140° F. and approximately 180° F. so asto place deformable material 90 in a deformable state. While in adeformable state, deformable material may be pressed against orotherwise allowed to conform to the shape of cast 70 to form custommedical mask 10. As deformable material 90 cools and hardens, custommedical mask 10 solidifies and will retain its custom shape. Inconfirming to cast 70, an interior surface of custom medical mask 10also conforms to the particular user's unique facial features. As aresult, the conformed interior surface of custom medical mask 10 has thesame orientation or positional relationship to oral appliance 20 (andthus to the particular user's teeth) that the conformed interior surfaceof impression material 50 had to oral appliance 20 (and thus to theparticular user's teeth).

Through the use of the methods and devices described above, a custommedical mask 10 may be formed substantially optimally for the particularuser's unique facial features. For example, custom medical mask 10 mayhave an interior surface that conforms substantially to the particularuser's unique facial features, such that the conformed interior surfaceof the custom medical mask 10 has substantially the same orientation orpositional relationship to the particular user's teeth as the conformedinterior surface of impression material 50 had to the particular user'steeth at the time that impression material 50 was applied to theparticular user's face. Custom medical mask 10 may be custom formed atleast in part through the maintenance of relationships (1) from theparticular user's teeth to oral appliance 20, and from oral appliance 20to orientation device 30, and (2) from the particular user's uniquefacial features to impression material 50, from impression material 50to orientation device 30, from impression material 50 and orientationdevice 30 to cast 70, and from orientation device 30 and cast 70 todeformable material 90, which forms body 12 of custom medical mask 10.Thus, by maintaining these relationships, the precise orientation orpositional relationship between the particular user's teeth and theparticular user's unique facial features may be utilized to form custommedical mask 10, which may provide improved fit, increased comfort,reduced leakage, and improved performance, whether for treating sleepdisordered breathing, for administering anesthesia, or for any othersuitable purpose for which the custom medical mask 10 is used.

Although the present invention has been described in severalembodiments, a plenitude of changes, substitutions, variations,transformations, and modifications may be suggested to one skilled inthe art, and it is intended that the present invention encompass suchchanges, substitutions, variations, transformations, and modificationsas fall within the scope of the appended claims.

1. A method of forming a custom medical mask for a particular user,comprising: while an oral appliance is positioned in the particularuser's mouth to receive the particular user's teeth and is coupled to anorientation device using a post of the oral appliance, applying animpression material over the orientation device and the particularuser's face including at least the particular user's mouth and a portionof the particular user's nose surrounding the particular user'snostrils, such that the impression material conforms to the orientationdevice and to the particular user's unique facial features; removing theimpression material from the particular user's face together with theorientation device, creating a cast of the particular user's face usingthe impression material together with the orientation device as a mold,such that the cast conforms to the impression material and theorientation device; and applying a deformable material to the cast ofthe particular user's face to form a custom medical mask for theparticular user, such that the deformable material conforms to the cast;wherein the custom medical mask is custom-fitted to the particularuser's unique facial features and custom-oriented to the particularuser's teeth.
 2. The method of claim 1, further comprising insertinginto the orientation device a second post corresponding to the oralappliance post, prior to applying the deformable material, such thatwhen the deformable material is applied to the cast the deformablematerial further conforms to the second post within the orientationdevice.
 3. The method of claim 2, further comprising coupling a lockingmechanism to the second post, prior to applying the deformable material,such that when the deformable material is applied to the cast thedeformable material further conforms to the locking mechanism.
 4. Themethod of claim 1, further comprising removing the impression materialfrom the particular user's face together with the orientation device andthe post of the oral appliance, such that when the deformable materialis applied to the cast the deformable material further conforms to thepost of the oral appliance.
 5. The method of claim 4, further comprisingcoupling a locking mechanism to the post of the oral appliance, prior toapplying the deformable material, such that when the deformable materialis applied to the cast the deformable material further conforms to thelocking mechanism.
 6. The method of claim 1, wherein the orientationdevice comprises at least one breathing passage configured to allow theparticular user to breathe when the particular user's mouth is coveredwith the impression material.
 7. The method of claim 1, wherein theorientation device comprises: an elongated tubular member configured toreceive the oral appliance post; and a restraining structure configuredto limit movement of the orientation device relative to the oralappliance.
 8. The method of claim 7, wherein the restraining structurecomprises a flange projecting from the elongated tubular member andconfigured to be positioned between the particular user's lips andteeth.
 9. The method of claim 1, wherein the deformable materialcomprises a thermoplastic polymer and is heated to transition to adeformable state prior to applying the deformable material to the cast.10. The method of claim 9, wherein the thermoplastic polymer comprises apolycaprolactone polymer.
 11. The method of claim 1, further comprising:creating openings in the custom medical mask corresponding to theparticular user's nostrils; and coupling a fitting for a clinical gasdelivery system to the custom medical mask for supplying a gas to theparticular user's nostrils through the openings in the custom medicalmask.
 12. A method for use in forming a custom medical mask for aparticular user, comprising: while an oral appliance is positioned inthe particular user's mouth to receive the particular user's teeth andis coupled to an orientation device using a post of the oral appliance,applying an impression material over the orientation device and theparticular user's face including at least the particular user's mouthand a portion of the particular user's nose surrounding the particularuser's nostrils, such that the impression material conforms to theorientation device and to the particular user's unique facial features;removing the impression material from the particular user's facetogether with the orientation device; and creating a cast of theparticular user's face using the impression material together with theorientation device as a mold, such that the cast conforms to theimpression material and the orientation device.
 13. The method of claim12, wherein the orientation device comprises at least one breathingpassage configured to allow the particular user to breathe when theparticular user's mouth is covered with the impression material.
 14. Themethod of claim 12, wherein the orientation device comprises: anelongated tubular member configured to receive the oral appliance post;and a restraining structure configured to limit movement of theorientation device relative to the oral appliance.
 15. The method ofclaim 14, wherein the restraining structure comprises a flangeprojecting from the elongated tubular member and configured to bepositioned between the particular user's lips and teeth.
 16. A method offorming a custom medical mask for a particular user, comprising:accessing a cast of the particular user's face that conforms to anorientation device and has been formed using an impression materialtogether with the orientation device as a mold, the impression materialhaving been: applied over the orientation device and the particularuser's face including at least the particular user's mouth and a portionof the particular user's nose surrounding the particular user'snostrils, while an oral appliance was positioned in the particularuser's mouth to receive the particular user's teeth and was coupled tothe orientation device using a post of the oral appliance, removed fromthe particular user's face together with the orientation device; andapplying a deformable material to the cast of the particular user's faceto form a custom medical mask for the particular user, such that thedeformable material conforms to the cast; wherein the custom medicalmask is custom-fitted to the particular user's unique facial featuresand custom-oriented to the particular user's teeth.
 17. The method ofclaim 16, further comprising inserting into the orientation device asecond post corresponding to the oral appliance post, prior to applyingthe deformable material, such that when the deformable material isapplied to the cast the deformable material further conforms to thesecond post within the orientation device.
 18. The method of claim 17,further comprising coupling a locking mechanism to the second post,prior to applying the deformable material, such that when the deformablematerial is applied to the cast the deformable material further conformsto the locking mechanism.
 19. The method of claim 16, wherein when thedeformable material is applied to the cast, the deformable materialfurther conforms to the post of the oral appliance, the post of the oralappliance having been removed together with the impression material andthe orientation device from the particular user's face.
 20. The methodof claim 19, further comprising coupling a locking mechanism to the postof the oral appliance, prior to applying the deformable material, suchthat when the deformable material is applied to the cast the deformablematerial further conforms to the locking mechanism
 21. The method ofclaim 16, wherein the orientation device comprises at least onebreathing passage configured to allow the particular user to breathewhen the particular user's mouth is covered with the impressionmaterial.
 22. The method of claim 16, wherein the orientation devicecomprises: an elongated tubular member configured to receive the oralappliance post; and a restraining structure configured to limit movementof the orientation device relative to the oral appliance.
 23. The methodof claim 22, wherein the restraining structure comprises a flangeprojecting from the elongated tubular member and configured to bepositioned between the particular user's lips and teeth.
 24. The methodof claim 16, wherein the deformable material comprises a thermoplasticpolymer and is heated to transition to a deformable state prior toapplying the deformable material to the cast of the particular user'sface.
 25. The method of claim 24, wherein the thermoplastic polymercomprises a polycaprolactone polymer.
 26. A system for use in forming acustom medical mask for a particular user, comprising: an oral appliancecomprising: an upper arch configured to be positioned within aparticular user's mouth to receive the particular user's upper teeth;and a post coupled to the upper arch and configured to protrude from theparticular user's mouth when the upper arch is positioned within theparticular user's mouth; an orientation device comprising: an elongatedtubular member configured to receive the oral appliance post to couplethe orientation device to the oral appliance; and a restrainingstructure configured to limit the movement of the orientation devicerelative to the oral appliance; and an impression material conformed tothe orientation device and the particular user's unique facial featuresand custom-oriented to the particular user's teeth via the orientationdevice and the oral appliance.
 27. The system of claim 26, wherein theorientation device further comprises at least one breathing passageconfigured to allow the particular user to breathe when the particularuser's mouth is covered with the impression material.
 28. The system ofclaim 26, wherein the restraining structure comprises a flangeprojecting from the elongated tubular member and configured to bepositioned between the particular user's lips and teeth.
 29. The systemof claim 26, further comprising a locking mechanism configured toreceive and secure the post of the oral appliance to couple the custommedical mask to the oral appliance.
 30. The system of claim 26, whereinthe particular user's unique facial features comprise the particularuser's mouth and a portion of the particular user's nose surrounding thenostrils
 31. A custom medical mask, comprising: a deformablethermoplastic polymer conformed to a custom mold of particular user'sunique facial features and custom-fitted to the particular user's uniquefacial features, the particular user's unique facial features includingportions of the particular user's face surrounding the particular user'smouth and at least portions of the particular user's nose; and a lockingmechanism configured to receive and secure a post of an oral applianceto maintain a custom orientation between the oral appliance and thecustom-fitted thermoplastic polymer.
 32. The custom medical mask ofclaim 31, further comprising a fitting configured to couple the custommedical mask to a clinical gas delivery system.
 33. The custom medicalmask of claim 31, wherein the thermoplastic polymer comprises apolycaprolactone polymer.